Twelve-Month RESILIENT Results Published

June 25, 2010—John R. Laird Jr, MD, et al have published 12-month results from the RESILIENT trial in Circulation: Cardiovascular Interventions (2010;3:267–276). RESILIENT is a randomized, multicenter trial comparing nitinol stenting and balloon angioplasty in the treatment of lesions in the superficial femoral artery (SFA) and proximal popliteal artery. The nitinol stent used in RESILIENT is the self-expanding LifeStent NT (Bard Peripheral Vascular, Tempe, AZ).

According to the investigators, the background of the study is that controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic SFA disease. There are conflicting data regarding the benefits of SFA stenting and the role of primary stenting compared with balloon angioplasty with provisional stent implantation.

In RESILIENT, a total of 206 patients, from 24 centers in the United States and Europe, with obstructive lesions of the SFA and proximal popliteal artery and intermittent claudication were randomized to nitinol stent implantation or percutaneous transluminal angioplasty.

As detailed by the investigators, the mean total lesion length was 71 mm for the stent group and 64 mm for the angioplasty group. Acute lesion success (< 30% residual stenosis) was superior for the stent group compared with the angioplasty group (95.8% vs 83.9%; P < .01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis.

At 12 months, the freedom from target lesion revascularization rate was 87.3% for the stent group compared with 45.1% for the angioplasty group (P < .0001). Duplex ultrasound-derived primary patency at 12 months was better for the stent group (81.3% vs 36.7%; P < .0001). Through 12 months, fractures occurred in 3.1% of stents implanted. No stent fractures resulted in loss of patency or target lesion revascularization, the investigators reported.

The RESILIENT investigators concluded that primary implantation of a self-expanding nitinol stent for moderate-length lesions in the SFA and proximal popliteal artery was associated with better acute angiographic results and improved patency rates compared with balloon angioplasty alone.